Traumatic Brain Injury
Conditions
Keywords
traumatic brain injury, virtual reality, Xbox kinect, balance
Brief summary
This study will evaluate the potential for improving balance for a single individual with a history of traumatic brain injury (TBI). The participant will engage in supervised therapy using commercial games on the Xbox Kinect. This study will also evaluate the viability of improving cardiovascular fitness using this intervention as well. The investigators hypothesize that balance improvements will occur and that using the Xbox Kinect is a viable way of improving cardiovascular fitness.
Detailed description
Various forms of virtual reality (VR) training have been recently used for rehabilitation of neurological impairments including postural stability and coordination. Virtual reality training has also been shown to increase motivation and attention through its use of novel goal-directed challenges. The Xbox Kinect gaming system allows the Veteran to perform challenging full-body and goal-oriented activities. Balance improvements using laboratory developed games have been demonstrated in those with a history of TBI. However, the investigators are specifically interested if improvements can be made using commercial games which can be utilized in physical therapy clinics more readily. Exercise gaming has been shown to provide adequate intensity exercise to improve heart health in the healthy population. However, such benefits have not yet been investigated using the Xbox Kinect for individuals with a history of TBI.
Interventions
OTHERXbox One Kinect Gaming
The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called Shape Up and Kinect Sports: Rivals to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant's abilities.
Sponsors
Washington D.C. Veterans Affairs Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* A male or female Veteran participant must have sustained traumatic brain injury greater than 1 year prior to baseline assessments * Veteran will be between the ages of 18 and 65 years old
Exclusion criteria
* Veterans with any cardiac condition that may cause sudden decompensation during cardiovascular testing and training (e.g., severe congestive heart failure and uncontrolled hypertension) * If Veteran has a significant cardiac history (as defined by American College of Sports Medicine), physician approval will be acquired prior to cardiac stress tests * Veterans with a previous history of behavioral impairments (e.g., aggression or inappropriate actions) that would preclude participation in standard physical therapy * Veterans with lower extremity amputation * Veterans that exhibit greater than mild cognitive impairments as shown by a score 17/30 or less on the Montreal Cognitive Assessment (MoCA). * Veterans that are unable to stand unsupported for at least 2 minutes * Veterans that are unable to ambulate on treadmill with bilateral hand support
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Gait Index (DGI) | Changes from (Baseline) Weeks 1,2,3,4,6,13,14 to (Intervention) Weeks 1, 3, 4, 6, 8 and to (Retention) Weeks 1, 2, 3, 4, 5 | The DGI is a common clinical measure used to evaluate dynamic balance and coordination during a person's daily activities. This test was developed by Shumway-Cook and features 8-items which assess a person's ability to walk while turning their head, changing speed, and navigating obstacles. The DGI is scored from 0 to 24 where higher scores indicate higher dynamic balance function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Limits of Stability (LOS) - Directional Control | (Baseline) Weeks 1,2,3,4,6,13,14; (Intervention) Weeks 1, 3, 4, 6, 8; (Retention) Weeks 1, 2, 3, 4, 5 | The LOS is performed on the NeuroCom Balance Manager. The LOS test is a goal-directed weight shifting task. The LOS-directional control measures the accuracy of an individual's movement of center of gravity during the task compared to a straight line. This is reported as a percentage without units. |
| Heart Rate at End of Mini-game | (Intervention) 2 times per week for 8 weeks | Heart rated recorded using heart monitor and chest strap at the end of each mini-game. |
| Heart Rate at Beginning of Mini-game | (Intervention) 2 times per week for 8 weeks | Heart rated recorded using heart monitor and chest strap at the beginning of each mini-game. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total Activity Time (TAT) | (Intervention) 2 times per week for 8 weeks | TAT is a measure of the total time that the Veteran will be participating in mini-game challenges during the 60 minute intervention session. |
| Time in Therapeutic Heart Rate Range (TTR) | (Intervention) 2 times per week for 8 weeks | TTR is the amount of time the Veteran spends within a target heart range of moderate to vigorous exercise prescribed as greater than 40% heart rate reserve. |
Countries
United States
Participant flow
Recruitment details
One Veteran recruited from Polytrauma department of Washington DC VA Medical Center during April 2015.
Participants by arm
| Arm | Count |
|---|---|
| Xbox One Kinect Gaming 15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.
Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called Shape Up and Kinect Sports: Rivals to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant's abilities. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Xbox One Kinect Gaming |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 37 years STANDARD_DEVIATION 0 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Dynamic Gait Index (DGI)
The DGI is a common clinical measure used to evaluate dynamic balance and coordination during a person's daily activities. This test was developed by Shumway-Cook and features 8-items which assess a person's ability to walk while turning their head, changing speed, and navigating obstacles. The DGI is scored from 0 to 24 where higher scores indicate higher dynamic balance function.
Time frame: Changes from (Baseline) Weeks 1,2,3,4,6,13,14 to (Intervention) Weeks 1, 3, 4, 6, 8 and to (Retention) Weeks 1, 2, 3, 4, 5
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Xbox One Kinect Gaming | Dynamic Gait Index (DGI) | Baseline | 12 units on a scale | Standard Deviation 0.38 |
| Xbox One Kinect Gaming | Dynamic Gait Index (DGI) | Intervention | 17 units on a scale | Standard Deviation 2.28 |
| Xbox One Kinect Gaming | Dynamic Gait Index (DGI) | Retention | 19 units on a scale | Standard Deviation 0 |
Secondary
Heart Rate at Beginning of Mini-game
Heart rated recorded using heart monitor and chest strap at the beginning of each mini-game.
Time frame: (Intervention) 2 times per week for 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Xbox One Kinect Gaming | Heart Rate at Beginning of Mini-game | 1st 5 Interventions | 90.71 Heart beats per minute | Standard Deviation 13.41 |
| Xbox One Kinect Gaming | Heart Rate at Beginning of Mini-game | 2nd 5 interventions | 87.79 Heart beats per minute | Standard Deviation 6.8 |
| Xbox One Kinect Gaming | Heart Rate at Beginning of Mini-game | 3rd 5 interventions | 77.95 Heart beats per minute | Standard Deviation 5.99 |
Secondary
Heart Rate at End of Mini-game
Heart rated recorded using heart monitor and chest strap at the end of each mini-game.
Time frame: (Intervention) 2 times per week for 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Xbox One Kinect Gaming | Heart Rate at End of Mini-game | 1st 5 Interventions | 109.13 Heart beats per minute | Standard Deviation 12.65 |
| Xbox One Kinect Gaming | Heart Rate at End of Mini-game | 2nd 5 interventions | 102.09 Heart beats per minute | Standard Deviation 5.78 |
| Xbox One Kinect Gaming | Heart Rate at End of Mini-game | 3rd 5 interventions | 92.87 Heart beats per minute | Standard Deviation 3.07 |
Secondary
Limits of Stability (LOS) - Directional Control
The LOS is performed on the NeuroCom Balance Manager. The LOS test is a goal-directed weight shifting task. The LOS-directional control measures the accuracy of an individual's movement of center of gravity during the task compared to a straight line. This is reported as a percentage without units.
Time frame: (Baseline) Weeks 1,2,3,4,6,13,14; (Intervention) Weeks 1, 3, 4, 6, 8; (Retention) Weeks 1, 2, 3, 4, 5
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Xbox One Kinect Gaming | Limits of Stability (LOS) - Directional Control | Baseline | 65 percentage of accuracy | Standard Deviation 4.64 |
| Xbox One Kinect Gaming | Limits of Stability (LOS) - Directional Control | Intervention | 68 percentage of accuracy | Standard Deviation 3.77 |
| Xbox One Kinect Gaming | Limits of Stability (LOS) - Directional Control | Retention | 67 percentage of accuracy | Standard Deviation 2.19 |
Other Pre-specified
Time in Therapeutic Heart Rate Range (TTR)
TTR is the amount of time the Veteran spends within a target heart range of moderate to vigorous exercise prescribed as greater than 40% heart rate reserve.
Time frame: (Intervention) 2 times per week for 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Xbox One Kinect Gaming | Time in Therapeutic Heart Rate Range (TTR) | 1st 5 interventions | 48.87 Minutes | Standard Deviation 7.68 |
| Xbox One Kinect Gaming | Time in Therapeutic Heart Rate Range (TTR) | 2nd 5 interventions | 51.20 Minutes | Standard Deviation 3.67 |
| Xbox One Kinect Gaming | Time in Therapeutic Heart Rate Range (TTR) | 3rd 5 interventions | 38.33 Minutes | Standard Deviation 9.78 |
Other Pre-specified
Total Activity Time (TAT)
TAT is a measure of the total time that the Veteran will be participating in mini-game challenges during the 60 minute intervention session.
Time frame: (Intervention) 2 times per week for 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Xbox One Kinect Gaming | Total Activity Time (TAT) | 1st 5 interventions | 27.13 Minutes | Standard Deviation 2.58 |
| Xbox One Kinect Gaming | Total Activity Time (TAT) | 2nd 5 interventions | 32.85 Minutes | Standard Deviation 1.9 |
| Xbox One Kinect Gaming | Total Activity Time (TAT) | 3rd 5 interventions | 30.5 Minutes | Standard Deviation 2.82 |